Contact Information
Address:
2160 W State Road 434, Longwood, FL 32779
Phone:
Website
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
2160 W State Road 434, Longwood, FL 32779
https://503bcompoundingpharmacy.com/
503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act. Located at 2160 W State Road 434, Longwood, FL 32779, this facility is dedicated to the large-scale compounding of sterile and non-sterile medications. As a 503B outsourcing facility, it adheres to rigorous federal standards for quality control, testing, and production, distinct from traditional compounding pharmacies. The primary mission of 503B Compounding Pharmacy is to provide healthcare providers at 2160 W State Road 434, Longwood, FL 32779 with access to high-quality, compounded medications that are essential for patient care but may be commercially unavailable or in short supply.
The services provided by 503B Compounding Pharmacy at its facility on 2160 W State Road 434, Longwood, FL 32779 are centered on the production of medications in larger batches for office use. This means that healthcare practitioners can maintain an inventory of vital medications to administer to patients directly within their practice. The compounding processes at 2160 W State Road 434, Longwood, FL 32779 are conducted under strict aseptic conditions and in compliance with Current Good Manufacturing Practices (cGMP). This ensures that every preparation, whether it is a sterile injectable, an ophthalmic solution, or an oral formulation, meets the highest possible standards for potency, purity, and sterility.
By operating as a 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, this pharmacy provides a critical service to the local medical community. It helps mitigate drug shortages by producing essential medications that are on the FDA drug shortage list. The team at 503B Compounding Pharmacy comprises skilled pharmacists and technicians who are experts in the science of compounding, utilizing advanced technology and meticulous procedures to ensure patient safety. For healthcare providers seeking a reliable source for office-use compounded medications, 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 stands as a trusted partner in patient care.
To learn more about the services available or to place an order, you can contact 503B Compounding Pharmacy directly. The team can be reached by phone at (407)993-1381. For comprehensive information about their compliance, available formulations, and the specifics of operating as a 503B outsourcing facility, visit their official website at https://503bcompoundingpharmacy.com/.
Frequently Asked Questions
1. What does it mean that 503B Compounding Pharmacy is an outsourcing facility?
It means that 503B Compounding Pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA under Section 503B of the FD&C Act. This registration requires compliance with more stringent federal quality standards, including Current Good Manufacturing Practices (cGMP), for the large-scale compounding of medications intended for office use by healthcare providers.
2. Can I as a patient walk into 2160 W State Road 434, Longwood, FL 32779 to get a prescription filled?
No. 503B Compounding Pharmacy primarily compounds medications for office use, which are then distributed to healthcare providers and facilities. Patients should contact their healthcare provider to discuss treatment options that may involve medications compounded at this facility.
3. How does a healthcare provider at 2160 W State Road 434, Longwood, FL 32779 order from your facility?
Healthcare providers and facilities can place orders for compounded medications by contacting 503B Compounding Pharmacy directly at (407)993-1381. The team will provide information on available formulations, ordering procedures, and delivery options to the 2160 W State Road 434, Longwood, FL 32779 location.
4. What kind of quality controls are in place at your facility?
As an FDA-registered 503B outsourcing facility at 2160 W State Road 434, Longwood, FL 32779, we operate under cGMP. This involves rigorous testing of ingredients (APIs), environmental monitoring, process validation, and sterility testing on finished products to ensure the safety, potency, and purity of all compounded preparations.
5. Where is 503B Compounding Pharmacy located?
503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779. This is the sole location of this FDA-registered outsourcing facility.